Events

Recall of Cook Inc Aprima Access Set

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Cook Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    19954
  • Event Initiated Date
    2016-04-27
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    Manufacturer is initiating a recall of listed products as they have identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/ or separation., preliminary investigation into this matter has identified that environmental conditions such as storage temperature, humidity and the use of vapourised hydrogen peroxide for whole-room decontamination within healthcare facilities, may be contributing to this occurrence., potential adverse events that may occur as a result if catheter polymer degradation coudl include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. (eg; device fragments in the vascular system, genitourinary system or other soft tissues).
  • Action
    Product to be returned to supplier

Device

Cook Inc Aprima Access Set

Manufacturer

Cook Incorporated